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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 33250400S
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 09/05/2016
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
After taking a x-ray it was noticed that the nail broke.
 
Manufacturer Narrative
The evaluation revealed the broken nail to be the primary product. No deviations were found during review of the manufacturing and inspection documents (dhr). The nail was documented as faultless prior to distribution. The evaluation revealed that the nail broke most likely in a fatigue fracture after a period of approx. 3 months of implantation. According to found damages the fatigue fracture had its origination in the anterior web at lateral. In this area significant material damage had weekend the web caused by misaligned drilling with the step drill; which presents an unintentional use error. Significant material deformation incl. Material seizing (bearing points) of the medial edge of the proximal drill hole was most likely caused by increased axial loading during the implantation period; which is considered as patient behaviour related. According to the operation reports and compared with provided x-rays there was no suspicious situation found in regards from technical point of view. A nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation. The affected implant is designed to withstand the normal loads during the implantation period, i. E. The implant must neither be exposed to peak loads nor to continuous stresses. Another prerequisite for a successful supply is undisturbed, normal bone healing. This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material. In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications. In this case the nail broke in an area where the material had been weakened significantly by intra-operative misaligned drilling which was considered as user related. Referring to additional material damage in and around the bearing points inside the proximal drill hole it could not be excluded that increased axial load during the implantation period. This would be considered as patient related. However, the operation report of the initial surgery did not contain instructions regarding weight bearing. Based on the above the nail breakage was not linked to a deficiency of the device, but was mainly user related, most likely contributed by the patient¿s load application. Review of complaint history, capa databases and risk analysis did not identify any conspicuity. The review of the risk assessment for the failure mode indicated the issue was addressed adequately. There are no actions in place related to the reported event for the subject product. No non-conformity was identified. The event was not linked to a deficiency of the device.
 
Event Description
After taking a x-ray it was noticed that the nail broke.
 
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Brand NameLONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6149746
MDR Text Key61592539
Report Number0009610622-2016-00606
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number33250400S
Device Lot NumberK0D0A57
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/06/2016 Patient Sequence Number: 1
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